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EMA: Concept paper on the revision of the guideline on the development of medicinal products for the treatment of ulcerative colitis

15.11.2012
The proposed guideline will replace the guideline on the development of medicinal products for the treatment of ulcerative colitis (CHMP/EWP/18463/2006). ...

EMA: Concept paper on the need of a guideline for clinical investigation of medicinal products for the treatment of chronic constipation

15.11.2012
The development of medicinal products influencing gut transit and defecation is one of the oldest principles of pharmacological treatment. Numerous products have been introduced into the market ...

EMA: Concept paper on the revision of the guideline on the development of new medicinal products for the treatment of Crohn’s disease

15.11.2012
The proposed guideline will replace the guideline on the development of new medicinal products for the treatment of Crohn’s disease (CPMP/EWP/2284/99 Rev. 1). ...

GMP: EU Commission publishes Version 2.0 of the Question and Answer Document on API Importation

08.11.2012
The European Commission has published a Version 2.0 of the Q&A document \"Importation of Active Substances for Medicinal Products for human use\" on 26 October. Version 1.0 was published on 10 ...

GMP: New EMA Guideline on Specifications for Impurities in Antibiotics

08.11.2012
EMA published the final \"Guideline on Setting Specifications for Related Impurities in Antibiotics\" (EMA/CHMP/QWP/199250/2009) which is coming into effect one year after on 30 June 2013. ...

GMP: EMA Assessment Report - on detected genomic fragments from endogenous and adventitious viral agents in live attenuated vaccines

08.11.2012
The sensitivity of modern detection methods increased considerably during the last years. The development includes that the detection limits of adventitious agents decreased considerably too. ...

MHRA: Public consultation (MLX380): European Commission’s proposal for a Clinical Trials Regulation

08.11.2012
The European Commission proposes to simplify the rules for the conduct of clinical trials and harmonise the way trials are conducted in the European Union. The proposed Regulation will replace the ...

GMP: New rules for Medical Devices published by the EU - significantly tightened Controls planned

02.11.2012
On 26 October 2012 the European Commission published proposals to ensure that especially patients can reap the benefits of safe, effective and innovative medical devices. But the proposals also ...

GMP: QP for Manufacturers of Medical Devices - New EU Requirement?

02.11.2012
Regarding medical devices, article 13 of the proposal introduces a new role for manufacturers of medical devices: A person responsible for regulatory compliance, subsequently referred to as ...

EMA: Concept paper on the need for revision of the guideline on the evaluation of medicinal products in the treatment of primary osteoporosis

02.11.2012
The proposed guideline will replace guideline on the evaluation of medicinal products in the treatment of primary osteoporosis (CPMP/EWP/552/95 Rev. 2). ...